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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
Product CodeMEH
Regulation Number 888.3353
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP IMPLANT SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP IMPLANT SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
CONFORMIS INC
  SUBSTANTIALLY EQUIVALENT 1
CONFORMIS INC.
  SUBSTANTIALLY EQUIVALENT 1
CORIN U.S.A.
  SUBSTANTIALLY EQUIVALENT 1
CORIN USA
  SUBSTANTIALLY EQUIVALENT 1
CORIN USA LIMITED
  SUBSTANTIALLY EQUIVALENT 2
DEPUY (IRELAND)
  SUBSTANTIALLY EQUIVALENT 1
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 2
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
EXACTECH INC
  SUBSTANTIALLY EQUIVALENT 2
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
GLOBAL MANUFACTURING TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 2
HOWMEDICA OSTEONICS CORP
  SUBSTANTIALLY EQUIVALENT 4
HOWMEDICA OSTEONICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
IMPLANTCAST GMBH
  SUBSTANTIALLY EQUIVALENT 1
IMPLANTCAST, GMBH
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 3
MEDACTA INTERNATIONAL, SA
  SUBSTANTIALLY EQUIVALENT 2
ORTHO DEVELOPMENT CORP.
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 6
SMITH & NEPHEW INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 5
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP
  SUBSTANTIALLY EQUIVALENT 1
STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
UNITED ORTHOPEDIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1192 1192
2015 487 487
2016 347 347
2017 382 382
2018 337 337
2019 340 340
2020 337 337
2021 372 372
2022 316 316
2023 334 334
2024 112 112

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 1124 1124
Adverse Event Without Identified Device or Use Problem 720 720
Device Dislodged or Dislocated 479 479
Device-Device Incompatibility 309 309
Appropriate Term/Code Not Available 305 305
Break 258 258
Fracture 245 245
Loose or Intermittent Connection 193 193
Nonstandard Device 168 168
Device Slipped 122 122
Corroded 111 111
Device Operates Differently Than Expected 109 109
Naturally Worn 85 85
Osseointegration Problem 82 82
Degraded 76 76
Metal Shedding Debris 74 74
Unstable 69 69
Material Integrity Problem 62 62
Malposition of Device 58 58
Mechanical Problem 57 57
Loss of Osseointegration 57 57
Detachment of Device or Device Component 56 56
Noise, Audible 51 51
Migration or Expulsion of Device 45 45
Material Erosion 45 45
Migration 38 38
Loosening of Implant Not Related to Bone-Ingrowth 37 37
Material Deformation 37 37
Inadequacy of Device Shape and/or Size 35 35
Positioning Problem 31 31
Patient-Device Incompatibility 27 27
Detachment Of Device Component 26 26
Material Separation 24 24
Device Contaminated During Manufacture or Shipping 24 24
Device Contamination with Chemical or Other Material 23 23
Device Appears to Trigger Rejection 18 18
Tear, Rip or Hole in Device Packaging 16 16
Unintended Movement 16 16
Difficult to Remove 14 14
Contamination 13 13
Sticking 12 12
Failure To Adhere Or Bond 11 11
Packaging Problem 11 11
Scratched Material 10 10
Device Packaging Compromised 10 10
Component Missing 10 10
Microbial Contamination of Device 9 9
Fitting Problem 9 9
Use of Device Problem 9 9
Compatibility Problem 9 9
No Apparent Adverse Event 8 8
Material Protrusion/Extrusion 7 7
Failure to Cut 7 7
Defective Device 7 7
Off-Label Use 7 7
Material Discolored 7 7
Crack 7 7
Material Fragmentation 7 7
Difficult to Insert 6 6
Product Quality Problem 6 6
Improper or Incorrect Procedure or Method 6 6
Contamination of Device Ingredient or Reagent 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Device Markings/Labelling Problem 6 6
Inaccurate Information 6 6
Connection Problem 5 5
Residue After Decontamination 5 5
Disassembly 5 5
Entrapment of Device 5 5
Disconnection 4 4
Difficult To Position 4 4
Separation Failure 4 4
Failure to Align 4 4
Device Disinfection Or Sterilization Issue 4 4
Patient Device Interaction Problem 4 4
Mechanical Jam 4 4
Device Damaged by Another Device 3 3
Device Damaged Prior to Use 3 3
Component Falling 3 3
Accessory Incompatible 2 2
Loss of or Failure to Bond 2 2
Positioning Failure 2 2
Inadequate Instructions for Healthcare Professional 2 2
Leak/Splash 2 2
Delivered as Unsterile Product 2 2
Unintended Collision 2 2
Defective Component 2 2
Device Inoperable 2 2
Failure to Osseointegrate 2 2
Loss of Power 2 2
Material Too Rigid or Stiff 2 2
Incorrect Device Or Component Shipped 2 2
Human-Device Interface Problem 2 2
Deformation Due to Compressive Stress 2 2
Calibration Problem 2 2
Device Contamination With Biological Material 2 2
Mechanics Altered 2 2
Material Twisted/Bent 1 1
Operating System Becomes Nonfunctional 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 1117 1117
Injury 792 792
Unspecified Infection 602 602
No Code Available 540 540
Joint Dislocation 306 306
Inflammation 271 271
Reaction 259 259
No Known Impact Or Consequence To Patient 232 232
No Information 229 229
Bone Fracture(s) 189 189
Fall 157 157
Ambulation Difficulties 150 150
Metal Related Pathology 145 145
Toxicity 134 134
Foreign Body Reaction 132 132
Insufficient Information 130 130
No Clinical Signs, Symptoms or Conditions 126 126
Inadequate Osseointegration 123 123
Failure of Implant 114 114
Limb Fracture 97 97
Discomfort 90 90
No Consequences Or Impact To Patient 89 89
Swelling 83 83
Osteolysis 79 79
Test Result 58 58
Joint Disorder 48 48
No Patient Involvement 46 46
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 36 36
Tissue Damage 32 32
Joint Laxity 31 31
Bacterial Infection 29 29
Limited Mobility Of The Implanted Joint 27 27
Loss of Range of Motion 26 26
Hip Fracture 25 25
Necrosis 24 24
Local Reaction 24 24
Hematoma 24 24
Fluid Discharge 21 21
Complaint, Ill-Defined 20 20
Numbness 15 15
Cyst(s) 15 15
Host-Tissue Reaction 15 15
Edema 14 14
Device Embedded In Tissue or Plaque 14 14
Weakness 13 13
Ossification 12 12
Staphylococcus Aureus 12 12
Muscle/Tendon Damage 12 12
Implant Pain 12 12
Physical Asymmetry 11 11
Swelling/ Edema 11 11
Joint Swelling 11 11
Muscular Rigidity 10 10
Fatigue 9 9
Disability 9 9
Burning Sensation 9 9
Unequal Limb Length 9 9
Chemical Exposure 8 8
Hypersensitivity/Allergic reaction 8 8
Death 8 8
Osteopenia/ Osteoporosis 7 7
Foreign Body In Patient 7 7
Arthralgia 7 7
Impaired Healing 7 7
Deformity/ Disfigurement 6 6
Patient Problem/Medical Problem 6 6
Wound Dehiscence 6 6
Arthritis 6 6
Hemorrhage/Bleeding 6 6
Scar Tissue 6 6
Unspecified Tissue Injury 6 6
Synovitis 5 5
Nerve Damage 5 5
Granuloma 5 5
Purulent Discharge 5 5
Abscess 5 5
Erosion 5 5
Heart Failure/Congestive Heart Failure 5 5
Inadequate Pain Relief 5 5
Depression 4 4
Pneumonia 4 4
Sleep Dysfunction 4 4
Post Operative Wound Infection 4 4
Erythema 4 4
Muscle Spasm(s) 4 4
Muscle Weakness 4 4
Seroma 4 4
Scarring 3 3
Sepsis 3 3
Itching Sensation 3 3
Laceration(s) 3 3
Paralysis 3 3
Calcium Deposits/Calcification 3 3
Cardiomyopathy 3 3
Aspiration/Inhalation 3 3
Weight Changes 3 3
Confusion/ Disorientation 3 3
Not Applicable 3 3
Peroneal Nerve Palsy 3 3
Non-union Bone Fracture 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Dec-17-2020
2 Corin Ltd II Sep-30-2021
3 Corin Ltd II Jun-11-2021
4 Corin Ltd II Mar-22-2021
5 Depuy Orthopaedics Inc. II Nov-21-2016
6 Exactech, Inc. II Sep-09-2022
7 Exactech, Inc. II Jan-18-2018
8 Exactech, Inc. II Nov-02-2015
9 Medacta Usa Inc II Feb-23-2013
10 Medacta Usa Inc II Feb-07-2013
11 Medacta Usa Inc II Jun-30-2011
12 Signature Orthopaedics Europe Ltd II Mar-25-2020
13 Signature Orthopedics Pty Limited II May-28-2021
14 Signature Orthopedics Pty Limited II Mar-06-2018
15 Smith & Nephew Inc II Sep-20-2012
16 Smith & Nephew, Inc. II Jan-04-2017
17 Smith & Nephew, Inc. II Jul-28-2016
18 Stryker Howmedica Osteonics Corp. II Feb-03-2015
19 Stryker Howmedica Osteonics Corp. II Apr-02-2014
20 Stryker Howmedica Osteonics Corp. II Jan-08-2013
21 Stryker Howmedica Osteonics Corp. II Jul-26-2012
22 Stryker Howmedica Osteonics Corp. II May-29-2012
23 Stryker Howmedica Osteonics Corp. II Jan-30-2012
24 Stryker Howmedica Osteonics Corp. II Oct-20-2011
25 Stryker Howmedica Osteonics Corp. II Feb-07-2011
26 Stryker Howmedica Osteonics Corp. II Apr-19-2010
27 Stryker Howmedica Osteonics Corp. II Dec-22-2009
28 Stryker Howmedica Osteonics Corp. III Sep-14-2009
29 Stryker Howmedica Osteonics Corp. II Aug-13-2009
30 Stryker Howmedica Osteonics Corp. II Jul-22-2009
31 Stryker Howmedica Osteonics Corp. II Jan-26-2009
32 Waldemar Link GmbH & Co. KG (Mfg Site) II Jan-11-2019
33 Zimmer Gmbh II Feb-20-2015
34 Zimmer, Inc. II Feb-04-2013
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